Parexel Blog

When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...

In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...

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FDA has previously made several public statements about its ability to conduct inspections and FDA personnel have also made policy comments in various public forums. Now that this guidance has...

The EO creates several new requirements aimed at building reliable, long-term domestic production of essential drugs and devices, including their components and input materials. These include...

There are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors...

Our regulatory affairs experts outline the new EAEU guidelines, and an effort to create global standards across the board. Read more...

Since the COVID-19 pandemic began in early 2020, the Center for Drug Evaluation (CDE) has maximized its capacity and optimized its regulatory procedures within the SAP framework to accelerate...

Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

With the continued threat of COVID-19, the way inspections will be performed and hosted will be significantly different from the pre-pandemic situation.

On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic. The section of the act...

Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.

On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. The summary of the...

Enabling patients to participate in clinic trials from home is both important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for COVID-19.